|Publication number||US7153293 B2|
|Application number||US 10/398,388|
|Publication date||Dec 26, 2006|
|Filing date||Oct 5, 2001|
|Priority date||Oct 6, 2000|
|Also published as||CA2424406A1, CA2424406C, CN1284607C, CN1468116A, EP1323442A1, EP1323442A4, EP1323442B1, US20040102739, WO2002030491A1|
|Publication number||10398388, 398388, PCT/2001/8784, PCT/JP/1/008784, PCT/JP/1/08784, PCT/JP/2001/008784, PCT/JP/2001/08784, PCT/JP1/008784, PCT/JP1/08784, PCT/JP1008784, PCT/JP108784, PCT/JP2001/008784, PCT/JP2001/08784, PCT/JP2001008784, PCT/JP200108784, US 7153293 B2, US 7153293B2, US-B2-7153293, US7153293 B2, US7153293B2|
|Original Assignee||Jms Co., Ltd|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (13), Classifications (16), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to a needle cover for actively preventing pollution and/or infection or other accidents caused by inadvertent puncture with an injection needle/puncture needle, wherein a winged needle as a whole can be retracted after its use into the needle cover (wing-retraction type inadvertent puncture protector), and the retracted winged needle can be retained with its needle tip being prevented from re-protruding from the needle cover, said needle cover requiring no slit to be aligned with the wing of the winged needle while retaining the needle, and the invention also relates to a winged needle comprising at least said needle cover (inadvertent puncture protector).
In medical facilities, pollution and/or infection due to inadvertent puncture with an injection needle/puncture needle has become a serious issue. Recently, to actively prevent accidents such as inadvertent puncture, a piece of legislation to enforce the use of inadvertent puncture protectors has been enacted in each state of the United States. Also, although no legislation has been enacted as in the Untied States, in many other countries including Japan and Europe, methods and/or means for preventing inadvertent puncture have attracted much attention of medical professionals.
The above described inadvertent puncture protectors herein refer not to simple, inexpensive conventional needle covers, but to ones with which the needle can be covered requiring no operation which may cause inadvertent puncture during the retention of the needle after its use, or ones with which the needle can be covered by an operation which is less likely to cause inadvertent puncture. Accordingly, even if they can effectively prevent inadvertent puncture, such devices would not be readily utilized in every medical facility and its branch. Moreover, adoption of such inadvertent puncture protectors would cause increases in cost as well as operators' work time. From these reasons, the above described means and/or methods for preventing inadvertent puncture have not prevailed as desired throughout current medical facilities for which reduction of medical expenses and simplification of operating processes are demanded.
As the injection needle and/or indwelling needle, a needle which is formed with a wing at its hub (needle base) are widely used to facilitate its grasping and indwelling. However, since the wing hinders the retention of the needle after use, the needle cover for retaining such winged needles tends to make the size of the needle larger as a whole compared with one for wingless needles. Therefore, some contrivance is needed to make the needle cover compact.
One simplest solution to solve the above-described problem is an inadvertent puncture protector in which a slit is provided in the needle cover; various such devices have been proposed. For example, JP, B, 06-7861, JP,A,08-206195, JP,B,04-36026, and others exemplify such those devices. However, since the above described needle covers must have the wing inserted along the slit, alignment was needed when retaining the wing, thereby making the operation cumbersome. Also it was necessary to carefully design the position, angle, and width of the slit of the needle cover such that the wing is readily inserted into the slit. Furthermore, the above-described slit must have a shape, size and structure to facilitate the sliding of the wing because the winged needle must be easily moved in the needle cover.
On the other hand, contrasting to the above described prior arts, means for retaining a puncture needle in a needle cover with no slit have also been proposed. One example is the needle cover disclosed in U.S. Pat. No. 5,030,212. The needle cover has a front end having an opening of a horn shape, through which the wing (mounted on the hub) is folded to be retained in the needle cover after use. This needle cover has no slit, and therefore there is no need to pay attention to the above described requirements concerning the slit, such as alignment, shape and size of the needle cover, thereby making the production and/or formation thereof easy.
However, the inadvertent puncture protection means exemplified by the above mentioned patent (U.S. Pat. No. 5,030,212) had a problem, as will be described below, concerning the retainability of winged needle and re-protrusion of the retained needle. First, regarding the retainability of winged needle, since the front end opening of the needle cover is shaped like a horn (radially expanded front end), it is easy to retain the winged needle into the needle cover in the beginning, but the mobility of the winged needle in the needle cover becomes extremely degraded at the transition portion to a cylindrical part with a smaller diameter. Also, if the inner diameter of the cylindrical part is increased excessively to improve the mobility, the needle cover will become too large and holding the winged needle retracted into the needle cover in position becomes difficult.
Needle covers with no slit had a common problem described below, though that is not specific disadvantage to the horn-type needle cover described above. That is, the mobility of the needle in a needle cover depends on wing-folding (retaining) state. For example, when the winged needle is inserted, in the beginning, into the needle cover with its part being trapped or twisted, the winged needle becomes extremely difficult to move. Otherwise, the retention of the needle itself becomes difficult. Thus, the mobility and/or the retainability of winged needle in a needle cover are affected by wing-folding state (in the needle cover). Therefore, it was difficult to secure a certain level of mobility and the retainability for a needle cover which places no restriction on the wing-folding state. Upon retracting a winged needle into a needle cover, keeping the wing at the position of a radially expanded part (with a horn like taper), the needle tip tends to move in the reverse direction (against the retraction direction) due to the taper and the restoring force of the folded wing. That is, there is a risk of re-protrusion of the retained needle. In the needle cover disclosed in U.S. Pat. No. 5,030,212, an open hole for engaging the wing is provided in the base end of the needle cover to prevent the re-protrusion of the needle. However, this engaging means of the winged needle not only caused increases in workload in the production process and in cost, but also had a problem in that the folded wing does not readily protrude from the opening hole at the needle retaining position and thus does not function well as the engaging means.
The first of the present invention is a needle cover comprising a front end opening through which a winged needle as a whole is retracted and a base end opening through which a flexible tube connected to the winged needle is passable, the needle cover being capable of retaining the winged needle as a whole with the needle tube of the winged needle being prevented from re-protruding, characterized by comprising wing-folding facilitating means which is formed in the front end opening and can fold the wing of the winged needle by gradually turning it upwardly when the winged needle as a whole is retracted into said needle cover through said front end opening.
The second of the present invention is a winged needle having a wing-retraction type inadvertent puncture protector, characterized by consisting of at least a winged needle, a flexible tube connected to said winged needle, and the above described needle cover being loosely fitted to said flexible tube.
The components of the needle cover of the present invention, and the configuration of a winged needle mounted with said needle cover will be described below specifically referring to each component.
A needle cover of the present invention has a front end opening through which a winged needle as a whole is retracted and a base end opening through which a flexible tube connected to said winged needle is passable, and the needle cover is capable of retaining the winged needle as a whole with the needle tube of the winged needle being prevented from re-protruding. The needle cover has a configuration, for example, consisting of a substantially flat bottom face, both side faces connected to said bottom face and a top face connected to said both side faces.
The size of the small-diameter opening of the base end side of the needle cover may be such that the flexible tube connected to the winged needle can pass through it, but it is preferable to make the size of the small-diameter opening about the same as the outer diameter of said flexible tube so that the winged needle will not accidentally move in the retraction direction, or slightly smaller than the outer diameter of the flexible tube so that, when the outer force applied on said flexible tube is released, the flexible tube is lightly supported by the small-diameter opening while the passage of the flexible tube is not hindered.
The needle cover of the present invention comprises a wing-folding facilitating means capable of folding the wing by turning it upward as described below, and more preferably comprises at least one of wing-retention support means as will be described below, slide-resistance reducing means for the wing, and wing-direction restricting means.
There is no limitation on the material for said needle cover provided that the material has enough rigidity to support the deformation of the wing of the winged needle. However, as the material of the needle cover, a transparent to semi-transparent material is preferable since the retraction position of the winged needle and the retaining condition of the wing can be confirmed. Examples include polyolefins such as polyethylene and polypropylene, polystyrene, acrylic resin, polyester resin, and the like.
Wing-Folding Facilitating Means
The wing-folding facilitating means refers to means for facilitating wing-folding by turning the wing of the winged needle upward when retracting the wing of the winged needle into the needle cover through the front end opening; examples of which include means in which the front end opening is configured to be an inclined open face.
Examples of the front end inclined open face adopted as said wing-folding facilitating means include one in which an inclined open face is formed with respect to the needle cover bottom face from the front end side upwardly toward the base end side of the needle cover as shown in
When the wing of a winged needle is rolled up by said inclined face and further pushed into the internal space of the needle cover from said front end opening toward the base end in a state that the side face or the base face of the wing, which has been rounded up smoothly, is in abutment with the end edge of the front end side opening of the needle cover, the end side bottom face of the wing comes into abutment with the internal space side of the bottom face of the needle cover, and the winged needle is readily retained into the needle cover in a state that the wing is turned around or turned around and twisted while the end side bottom face of the wing being abutting against the internal space side of both side faces or the internal space side of the top face of the needle cover. The wing which thus has been readily rolled up is very easy to be retained in the needle cover.
Further, at this moment, since the turned wing end is folded in the direction nearly opposite to the retraction direction (base end side), the winged needle is easier to be moved in the retraction direction (forward direction), and difficult to be moved in the re-protruding direction (reverse direction) since the wing end acts as a trap. Therefore, there is no need for providing special re-protrusion prevention means on the needle cover. Also, for the movement in the forward direction, the winged needle can hold its retaining position in the cover preventing its free movement while no external force is applied, since the wing abuts against the internal space wall of the needle cover.
In the needle cover of the present invention, the relation between the area S of the wing specified by the width and length of the wing, and the inner perimeter L at the front end opening of the needle cover is also important. When the wing area S is excessively larger than the inner perimeter L, the wing will fill the needle cover to the full thus making the retention of the winged needle difficult. On the contrary, when the inner perimeter L is too large with respect to the wing area 5, it will hinder the operation and, therefore, become a waste.
Particularly, provided that the inner perimeter of the inclined opening of said needle cover be L (
After all, said L may be 3 to 9 cm, preferably 4 to 8 cm, and more preferably about 5 to 7 cm.
Wing-Retention Support Means
Since the folding condition of the winged needle in the needle cover according to the invention is determined at the moment when the wing is inserted, it is possible to stabilize and uniform the retaining (folding) condition of the wing of the winged needle in a needle cover by providing wing-retention support means particularly in the front end opening.
Said wing-retention support means may be configured such that the side face and/or top face of at least the front end opening has a convex shape protruding in the outward direction, that is the opposite direction to the inside of the internal space of the needle cover. Examples of such configuration include one in which both side faces 4 a, 4 b of the needle cover bulge forming a convex shape outwardly in the axial direction (opposite side of the inside of the internal space) of the needle cover including the front end opening (as with
When both side faces 4 a, 4 b of at least front end face of the needle cover bulge outwardly in a convex shape as described above, the wing is more readily rolled up when retracting the wing of the winged needle into the front end opening. Further, the wing is placed along the bulging part 12 which is of a outwardly convex shape and the wing tip part is folded in the predetermined direction, allowing the wing to be more smoothly folded and thereby more readily inserted into the needle cover rather than a case in which both side faces 4 a, 4 b of the needle cover are vertical. Thus, it is possible to make the retention (folding) condition of the wing of the winged needle in the needle cover more stable and uniform.
Furthermore, the needle cover thus formed with a bulging part shows better reproducibility of the retaining condition when further repeating the retaining operation. And unless there is no significant deviation during retraction, substantially same retaining condition will be induced. On the contrary, when the wing is trapped in the needle cover, or the wing or the hub is rotated by 90 to 180 degrees, there arises large resistance when retracting the winged needle into the cover, thus allowing to prevent retraction of the wing in an improper condition.
Furthermore, when said bulging part formed at the front end opening is formed in the axial direction in the both side faces of the needle cover, it will provide significant effect not only on the retainability of the wing but also on the mobility thereof.
Though the above described bulging part may be formed through the entire region in the axial direction of both side faces of the needle cover as described above, it will be sufficient to form it in the range from the front end opening, which relates to the folding of the wing upon starting the wing retention, to the portion of both side faces against which the wing abuts when it is completely covered with the needle cover.
A preferable position in the both side faces in the vertical direction for forming the bulging part is to be decided by the position where the wing of the winged needle is formed, but generally about the middle part between the bottom face and the top face of the needle cover would be preferable since this would give a larger tolerance for producing the wing-retention effect when retaining the winged needle into the needle cover.
Further, the shape of the bulging part may be either one having an angular apex 12 bulging toward outwardly (lateral direction with respect to the axial direction) as shown in
A wing-retention support means having a shape of the above-described bulging part may be formed on the top face of the needle cover, although that will have less effect than the case in which the bulging part is formed in the side faces of the needle cover. In this case, it is preferable to form a bulging part in the top face in addition to the bulging part formed in the side face of the needle cover. This bulging part formed on the top face of the needle cover also preferably has a shape which is formed by bulging the top face of the needle cover outwardly (upwardly). And its shape may be either one having an angular apex bulging outwardly (upwardly), or one having a curved apex (or bulging part) bulging outwardly (laterally) as with the bulging parts formed on the side faces. And, upon forming a bulging part on the top face of the needle cover, when an outwardly (upwardly) bulging shape is formed as shown for example in
Moreover, this angular or curved bulging part on the top face needs not to be formed along the entire length of the axis of the needle cover, and it will be sufficient to form it in the range from the front end opening, which relates to the wing folding upon starting the wing retention, to the portion of both side faces against which the wing abuts when it is completely covered with the needle cover.
Wing Slide-Resistance Reducing Means
As other wing-retention support means, following slide-resistance reducing means may be adopted. That is, at least a part of the edge of the front end opening which may abut against the wing when retaining the winged needle into the needle cover is rounded to reduce the slide-resistance or, an emboss finishing may be applied to form tiny irregularities on at least a part of the portion which may abut against the wing inside the internal space of the needle cover to reduce the slide-resistance.
Wing-Direction Restricting Means
Further, as another wing-retention support means, it is desirable to provide direction restricting means which is capable of preventing improper retention of the winged needle into the needle cover and restricting the advancement and retreat of the needle in the cover generally to the predetermined direction.
One example of said direction restricting means is configured such that a straightline stripe projection 14 is formed in a proper portion in the inner surface of the internal space of the needle cover as shown in
Furthermore, since, in most cases in which the wing has been retained into the cover, the wing end is placed on the internal space side of the top face of the needle cover, the portion in which the above described stripe projection 14 is formed preferably in the internal space of the top face, and particularly the middle part of the internal space of the top face is more preferable since intended direction restriction effect may be produced most effectively.
In the case of the winged needle equipped with said wing-direction restricting means, the wing tip is moved while abutting against said stripe projection 14 thereby being geometrically restricted. Therefore the wing will show a linear track along the stripe projection, and therefore when the winged needle is retained as being inclined against the cover, or when the bottom face or the cover is not parallel with the flat part of the wing, and if there is no large deviation, the position of the wing end is restricted by the stripe projection 14, and thus the retention condition may be readily adjusted.
Holding (Pressing) Member
Providing an arcuate projection 21 on the top face near the base end opening as shown in
In the winged needle having inadvertent puncture prevention device according to the present invention, its characteristic features resides mostly in the needle cover side. However, the wing of the winged needle may have a specific structure or configuration so that the winged needle can be readily retained into the needle cover.
Such examples include a wing which has a hardness of 10 to 100 as specified by JIS-A, or a wing having a structure which has a tendency of bending upward by means of said wing-orienting means of the needle cover. Examples of the wing having such structure include one having a structure which will readily become prone to bend upward, or one having a structure which has acquired such feature in advance.
Furthermore, for the winged needle used in the present invention, any known conventional foldable winged needle, for example, a winged needle of which wing is flexible can be adopted. Operational procedure of the winged needle of the present invention
The needle tube of the winged needle is punctured into the body of the patient, with a needle cover being loosely fitted to the flexible tube of the winged needle to which the tube is connected. While the winged needle is being punctured into the patient, it is often the case that the wing is fixed to the skin of the patient with a tape or the like. When infusion of pharmaceutical liquid or blood sampling is finished, the tape is removed and then the winged needle is withdrawn from the patient body while pressing the needle tip with sterilizing cotton. At this moment, the needle tube is retained in the needle cover concurrently with the withdrawal of the winged needle, the withdrawal operation and retaining operation into the needle cover are conducted by pulling the tube toward the base end side (opposite to the needle tip) while pressing a part of the needle cover with a finger.
By way of more detailed explanation, the present invention will be described with reference to the appended drawings and embodiments.
The winged needle shown in
The needle cover 1 is formed at its front end with an opening (large-diameter opening 7) through which the winged needle 2 can be passed with the wing 6 being folded upward, and another opening 9 which has a diameter slightly smaller than that of the tube and through which the flexible tube 8 of the winged needle can be passed.
The needle cover 1 shown in
The needle cover 1 shown in
The needle cover 2 in
The needle cover of
Thus, since the wing tip 11 abuts against the guide rib 14, and the winged needle 2 moves along it in the needle cover 1, the tip of the needle 13 would not stagger while moving. It is often the case in clinical practices that the winged needle 2 is required to be retained in the needle cover 1 as soon as it is withdrawn from the patient body. In such cases, the above described guide ribs 14 are effective. That is, when withdrawing the needle 13 from the patient's body while retaining the needle 13 into the cover 1, the guide ribs 14 would restrict the direction of the needle tip, thereby allowing the needle to be withdrawn in a straight fashion. Staggering of the needle tip during the withdrawal may pose a risk of damaging the blood vessels. Therefore, with the staggering of the needle tip being prevented, the operator would not be distracted by the needle tip, and will be able to retract the tube 8 a of the base end side while pressing only the needle cover. And, by retracting the flexible tube 8, the needle will be withdrawn from the patient body and, at the same, retained into the needle cover.
The needle cover 1 of
The winged needle of
The winged needle 2 in
Since the winged needle 2 used in
The folding effect or mechanism of the wing when retaining the wing of the winged needle of the present invention will be explained in
That is, the winged needle is retained into the needle cover by pulling the base end side tube 8 a toward the base end while pressing the needle cover 1. And, since the front end opening is formed with an inclination face and therefore, upon withdrawing the winged needle 2 into the needle cover 1, the wing 6 would be pressed against the both inclined side faces 4 a, 4 b of the large-diameter opening 7, thereby gradually (naturally) rolling up the wing 6 along the inclined faces. In such state, further pulling the tube 8 a toward the base end would cause the wing 6 to be retained in the internal space of the needle cover 1 in a state that the front end 11 of the wing is turned around toward the needle tube 13. At this moment, since the both wing ends 11 a, 11 b are retained by being folded to the needle tube 13 side, the winged needle is easier to be withdrawn toward the base end side (forward direction) and less easy to move in the reverse direction (needle tip side). The needle cover in
The needle cover shown in
The needle cover shown in
Since the needle cover of
The needle cover 1 of the present embodiment, as shown in
The width of the bottom face is 18.3 mm and formed to be nearly flat. The bulging part 12 is formed at a height of about 3 to 4 mm from the bottom face, and the apex angle β is about 131 degrees. The bulging part 12 is provided on both side faces 4 a, 4 b, and its end portion starts from the large-diameter opening 7 to an extent of 55.0 mm in the axial direction.
The large-diameter opening 7 on the front end side is configured to have an inclination angle α of 45 degrees, the area of the opening being about 330 mm2. The small-diameter opening 9 has an outer diameter of 4×5 (irregular circle) mm which is slightly smaller than the outer diameter of the tube 8 of 5.5 mm. The top face 5 of the needle cover is provided on its outer surface with a plurality of arcuate projections 21 having a height of 2 to 3 mm and a width of 0.2 mm as the holding means. Two stripe ribs 14 are formed in the central part of the internal space of the top face 5 as the direction restricting means. The two stripe ribs 14 placed about 1.5 mm apart and parallel in the axial direction, are formed starting from the large-diameter opening 7 and extending over 35.0 mm in the axial direction. The height of the ribs is about 1.8 mm.
The wing 6 of the winged needle is configured such that the base end edge 16 are inclined by 3 degrees with respect to the plane normal to the tube axis, and the inclination angle γ of this base end opening is changed to facilitate the retaining operation. The length of the needle tube protruding from the needle base is 22 mm, axial length of the needle base where the wing is formed is about 10 mm.
The needle cover is made of polypropylene, and the portion of its internal space which contact with the wing is finished by an emboss process. Also, the wing of the needle is made of vinyl chloride resin having a hardness of 70 as specified by JIS-A. The thickness of the wing is about 1.0 mm, and its material is soft and easily formed.
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|US5030212 *||Jul 30, 1990||Jul 9, 1991||Rose Peter J||Puncture guard for needle administration set|
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|US5266072||Sep 21, 1992||Nov 30, 1993||Utterberg David S||Guarded winged needle assembly|
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|US5928199||Sep 22, 1997||Jul 27, 1999||Nissho Corporation||Winged needle assembly|
|EP0261835A2||Sep 9, 1987||Mar 30, 1988||Critikon, Inc.||Improved winged catheter assembly|
|JPH0436026A||Title not available|
|JPH01212561A||Title not available|
|JPH08206195A||Title not available|
|JPH11319086A||Title not available|
|WO1995024232A1||Mar 9, 1995||Sep 14, 1995||Noble House Group Pty. Ltd.||Protection assembly|
|U.S. Classification||604/263, 604/110|
|International Classification||A61M5/00, A61M5/32, A61M5/158, A61M25/02, A61M25/06|
|Cooperative Classification||A61M5/3243, A61M25/02, A61M25/0637, A61M25/0612, A61M25/0631, A61M5/158|
|European Classification||A61M25/06D3, A61M25/06D2, A61M5/158|
|Apr 7, 2003||AS||Assignment|
Owner name: JMS CO., LTD, JAPAN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:NAKAJIMA, MASAKUNI;REEL/FRAME:014282/0979
Effective date: 20030318
|Jun 10, 2008||CC||Certificate of correction|
|Dec 23, 2008||CC||Certificate of correction|
|May 27, 2010||FPAY||Fee payment|
Year of fee payment: 4
|May 28, 2014||FPAY||Fee payment|
Year of fee payment: 8